Neurotrophin Expression in Infants as a Predictor of Respiratory and Neurodevelopmental Outcomes

NCT ID: NCT03373539

Last Updated: 2025-11-26

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 70 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-12-31
• Study Completion Date: 2019-08-31

Brief Summary

Important developmental processes continue until the completion of 40 weeks gestation. Even during fetal life, intrinsic and environmental factors determine the balance between health and the onset and development of diseases. Thus, it is crucial to understand the mechanisms that regulate normal development and the pathways that contribute to disease pathogenesis.

Neurotrophins are a family of four proteins that support the growth and survival of neurons. Their secretion increases during brain development, when new neurons are being formed and existing ones are branching to assemble complex neuronal circuits. In addition to their role in promoting neuron growth and development, neurotrophins are also a product of neuronal activity. Neurotrophins are also responsible for the maintenance of peripheral sensory neurons, including those in the lungs. Airway innervation is responsible for many aspects of lung function including the regulation of airway smooth muscle tone, mucus secretion, and reactivity; therefore, a physiological expression of neurotrophins in the lungs is required for normal lung function.

Detailed Description

Currently, there is no reliable method to identify infants who will have poor neurodevelopmental and respiratory outcomes. The ability to make such predictions would be beneficial for both making care decisions in the neonatal intensive care unit and for identifying infants who require earlier and more intense intervention. We intend to determine if neurotrophins can be utilized to predict an infant's long-term outcomes. Neurotrophins are a family of four proteins that support the growth and survival of neurons. Their levels have been shown to increase with brain development and decrease with brain injury. Neurotrophins have also been associated with development of airway injury in the neonate and later respiratory disease such as asthma. We plan to correlate serum neurotrophin levels with respiratory outcomes and neurological outcomes.

Conditions

Bronchopulmonary Dysplasia; Chronic Lung Disease

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

intubated infants in the Neonatal Intensive Care Unit (NICU)

Exclusion Criteria

unwilling or unable to give or obtain informed consent

• Minimum Eligible Age: 1 Day
• Maximum Eligible Age: 4 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Cleveland Clinic

OTHER

Sponsor Role: lead

Responsible Party

Fariba Rezaee

Staff

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Giovanni Piedimonte, MD

Role: PRINCIPAL_INVESTIGATOR

The Cleveland Clinic

Locations

Cleveland Clinic

Cleveland, Ohio, United States

Countries

United States

Other Identifiers

14-1270

Identifier Type: -

Identifier Source: org_study_id